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COMPLETED
NCT00989469
PHASE1/PHASE2

Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

Summary

A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.

Official title: SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2009-02

Completion Date

2012-02

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

Nexavar (Sorafenib) and irinotecan (Campto)

Sorafenib administrated continuously orally 400 mg twice daily (a daily total dose of 800 mg). Irinotecan 180 mg/m² will be administered IV for 90 minutes every 2 weeks. The first dose of sorafenib will be administered after the first perfusion of irinotecan 180 mg/m² at the first infusion

Locations (5)

Centre Oscar Lambret

Lille, France

Hopital Saint Eloi

Montpellier, France

Centre Rene Gauducheau

Nantes, France

Centre Antoine Lacassagne

Nice, France

CHU Robert Debre

Reims, France